Wednesday, 25 June 2014

Meetings of Experts - Facing the Fear

  • Meetings are designed to identify points of agreement and disagreement
  • Meetings are not mini-trials
  • Agendas are not to be used for leading questions or cross-examination
  • A standard form of preamble and guidance to experts should be agreed for use in clinical negligence claims
  • If an expert significantly alters his opinion or gives an opinion which was not in his report, questions ought to be allowed

Discussions or meetings of experts are a crucial part of clinical negligence litigation. One of the first documents a trial judge will turn to is the experts' joint statement. Agreements recorded in joint statements are effectively set in stone. Experts' meetings terrify litigators.

For a control freak litigator - and many litigators fall into that category - preparing for and reading the report of meeting of experts is a traumatic experience.  They are scarred by memories of experts, robust in conference and on paper, making vital concessions when in one-to-one discussions with their opposite number. They worry that experts will feel intimidated about speaking their minds in a meeting (see Hubbard-v-Lambeth [2001] EWCA Civ 1455), will horse-trade with a view to avoiding trial, will be unprepared or will use loose language which might be disastrous for the case. They are bitter that the experts themselves are unaffected by the consequences of these calamities - as claimants and their lawyers see their financial dreams crumble, or defendants and theirs see their expectations of triumph turn to dust, the experts walk away from the wreckage, fees paid, sometimes seemingly unaware of the carnage they have wrought.

So expert witnesses should understand why they are inundated with pre-meeting correspondence and provided with twenty page agendas complete with preambles and footnotes. Such zealous preparation is a response to past experience. Experts may not understand why lawyers are so exercised with the use of the word "would" over "could", "mandatory" over "advisable" etc. but everything can turn on those details. The litigator has a heightened sensitivity to every nuance at the time of the experts' meeting. Nothing can be missed in preparing the ground.

What litigators want is for their own expert to stand firmly to his existing evidence and the opposing expert to cave in. Is that a realistic expectation? And is this attempt to exercise control over the meeting misplaced? What is the point of a joint meeting if there is no opportunity for changing opinions and if the experts simply re-state the opinions given in their reports? Do we really want experts to have a meeting in order to produce a Scott schedule setting out the contents of their written evidence (as care experts very often do). The experts are, after all, reporting to the court. If their discussions produce concessions, clarification and changes - if they narrow the issues - that is right and proper. Better that they bend or bow at this stage than in the witness box at trial.

As a lawyer acting for a client, I want to help that client secure the best possible outcome from their case. As a lawyer looking at the system of resolving clinical negligence disputes as a whole I wonder whether it is time to take stock of how these meetings are managed.

The rules are straightforward and the practice direction clear.

When joint meetings were first introduced it was suggested that lawyers might be present to guide the discussions. This never caught on. You can envisage an LA Law/Ali McBeal scenario where a meeting of experts is continually interrupted by lawyers seeking time out to have private discussions with their own expert, interventions to object to certain questions being asked etc. Sensibly the practice direction foresees that problem and provides that:

9.4 Unless ordered by the court, or agreed by all parties, and the experts, neither the parties nor their legal representatives may attend experts discussions.

9.5 If the legal representatives do attend –
(i) they should not normally intervene in the discussion, except to answer questions put to them by the experts or to advise on the law; and
(ii) the experts may if they so wish hold part of their discussions in the absence of the legal representatives.

I have not had one case in which lawyers attended a discussion between experts. Indeed most "meetings" are, I believe, held by telephone and the practicalities of at least two solicitors or barristers joining in would be difficult to manage. Instead, perhaps frustrated by their lack of direct involvement, lawyers seek to control what happens at experts' meetings by producing long and detailed agendas. 

Agendas for meetings in clinical negligence cases are now standard practice. In my experience (and this is partly a plea of mea culpa) they have become increasingly lengthy, repetitive and detailed.  It is not at all uncommon for parties to fail to agree on the contents of the agenda. It is irritating for all concerned when that happens. The result is often that two agendas are presented to the experts, causing confusion and risking inconsistency in the responses. Negotiations as to the contents of agendas have become unedifying trials of strength.

As a result, I have seen several cases where the agendas have clearly got "out of hand". They become substitutes for examination in chief and cross-examination. I confess to having conducted cross-examination by agenda myself. The meeting is not a substitute trial as the practice direction makes clear:

PD 9.3 provides that:
Where the experts are to meet, the parties must discuss and if possible agree whether an agenda is necessary, and if so attempt to agree one that helps the experts to focus on the issues which need to be discussed. The agenda must not be in the form of leading questions or hostile in tone.

So agendas are not always necessary but where they are deployed the practice direction should be borne in mind. Perhaps the following guidance would assist in reducing the length of agendas and helping the experts.

1. An agenda for a meeting is a list of topics for discussion not a series of tightly worded sequential questions. My dictionary defines "agenda" as a "plan of things to be done or topics to be discussed". Can you imagine an agenda for a board meeting, which comprised questions such as "bearing in mind the economic data published on 1 April, the likely outcome of the recent productivity drive and any other circumstances you think relevant (stating what those circumstances are and why you believe them to be relevant) on the balance of probabilities should a pay rise be (a) offered to or (b) discussed  with the assistant manager? If so, what level of pay rise do you say should be offered or discussed, setting out your reasons." No, an agenda for a meeting would simply say: "Assistant Manager's Pay for 2014-5". 

2. List the issues which are in dispute (to which the experts' specialist knowledge is relevant) and those which are already agreed. The purpose of the meeting is to determine whether there is agreement or disagreement on those issues which remain in dispute. Once the issue for discussion is identified on the agenda, any questions should be directed to determining whether there is agreement between the experts on the issue or, if disagreement, the reasons for the disagreement. The agenda should not be designed to test out the opposing expert or to help your own expert. 

3. The experts should be provided with a copy of the relevant provisions of CPR Part 35 and the Practice Direction. Guidance as to the mechanics of drawing up the statement, quoting and producing published papers etc. is also useful. If an expert has referred to academic papers in his report, copies must have been provided to the opposing expert before the meeting so that discussions can include them.

4. The provision of an agreed, short statement of the tests for clinical negligence and causation, where appropriate to the issues in dispute, is very helpful.

5. It would be extremely useful if the NHSLA, MDU, MPS and say APIL or other claimant representative bodies could agree a standard preamble and briefing for experts' meetings. This would include a short statement of the legal test for negligence, causation etc. It could include standard advice about the mechanics of the meeting, and set out the relevant rules and practice direction. Experts will not thank lawyers for a three page analysis of what constitutes negligence, but a short and accurate statement which can be used in all cases would be very helpful. At present this is subject to agreement between parties on a case by case basis. Recently it seems to have become a matter of considerable dispute. That seems to me to be a waste of time, money and effort which an agreed standard form would save.

6.  Ensure that each expert has seen the same documentation (witness statements, other experts' reports etc.) Perhaps a file containing relevant documentation can be agreed, prepared and given to the experts prior to the meeting.

7. Consider the order in which meetings should be held and whether one pair or group of experts may need to consider the joint statement of another pair or group before holding their meeting.

8. Consider whether there is merit in experts from different disciplines meeting together, particularly where their fields of expertise and the issues on which they are giving opinions overlap or interrelate.

9. Remind the experts that if an expert does make a significant concession they should explain why they have done so: PD 9.8 provides that if an expert significantly alters an opinion, the joint statement must include a note or addendum by that expert explaining the change of opinion.

The way the rules on Pt 35 questioning are framed, it is not clear that questioning should be put after an experts' meeting is reported. Questions are allowed to be put to an expert "about his report" and within 28 days. The statement following an experts' meeting is perhaps not a "report". That seems unduly restrictive, particularly if an expert has changed his opinion or has given an opinion on an issue on which he has previously been silent. Questioning would then serve to clarify the issues and evidence. Sometimes parties agree directions in advance which allow questioning of experts after the joint statement. Perhaps Part 35 should be changed to allow that to be standard practice where an expert has given new or significantly altered evidence in a joint statement.

Whatever approach litigators choose to take to discussions between experts, they will always be times of heightened stress and fear.

Friday, 20 June 2014

Ten Reasons to Oppose the Saatchi BIll

Without waiting for the results of the government's consultation on his earlier draft, Lord Saatchi has introduced a new version of the Medical Innovation Bill into the House of Lords. It is due to have a second reading on 27 June 2014.

A copy of the new draft Bill can be found here.

Here are ten reasons to oppose the Bill:

1.It is based on the false premise that the existing law of clinical negligence is a barrier to medical innovation.  

Lord Saatchi's publicly stated belief is that "The law defines medical negligence as deviation from  standard procedure. But as innovation is deviation, non-deviation is non-innovation. This is why there is no cure for cancer." Of course, the law does not define medical negligence as deviation from standard procedure, but as acting in a way which no responsible body of relevant medical professionals would condone. As it happens almost every medical, research or patient body which  responded publicly to the government's consultation said it had no evidence that litigation or the fear of litigation is an obstacle to innovation. That ought to put paid to the bill. It is designed to help the medical profession address a problem which the medical profession does not believe is a problem.

2.It will not stimulate innovation. 

Progress in treating cancer or other conditions is unlikely to be advanced by a lone doctor whose treatment no other responsible body of medical opinion supports. Even if an individual doctor has a brilliant, innovative idea for treatment, why would he not want to have that tested and discussed by other doctors, and their agreement that it is a reasonable treatment to attempt, before using it on a patient? This bill does not require him/her to do so. The bill does nothing to address research, funding or the regulation of new treatments.

3.It will replace the Bolam test of whether treatment decisions are negligent. 

The Bolam test has stood the test of time (over 50 years). It is flexible and simple to understand. Under the bill doctors will still be able to claim that their treatment is not negligent if supported by a responsible body of opinion, but the bill provides them with a defence if the treatment is not supported by a responsible body of   opinion. Thus the current level of protection for patients which the common law provides, which some           believe is too weak as it is, will be significantly weakened.

4.It will prevent patients from seeking redress for harm caused by negligent treatment 

Patients harmed by a doctor's treatment, or their families if the patient dies as a result of the treatment, would no longer be able to claim redress from the doctor giving the harmful treatment even if the treatment would not be supported by any other doctor. This is true also of decisions not to treat, even if beneficial treatments are available but are not given. Surely there are better ways of promoting innovation than by depriving injured patients of a right of redress?

5. It does not require a doctor's decisions to be rational or to be authorised or sanctioned by any other doctor.

It merely requires a doctor to go through certain procedural requirements when making a treatment decision, but does not require a decision to treat to be rational or reasonable or for it to be agreed or sanctioned by any other doctor or authorised person. The individual doctor is free to disregard the opinions of others. The bill's proponents keep repeating the claim that it requires doctors to secure agreement for the proposed treatment. It does not.

6.It applies to all treatment, not just innovative treatment

"Innovative treatment" is not defined and so the bill applies to any treatment which departs from existing range of  accepted treatment, whether innovative or otherwise. Treatment is defined as including decisions not to treat, and to include management of a patient. Thus the bill has a very wide ambit. Although it is called the Medical Innovation Bill it is not at all focused on innovation. It is not restricted to treatment for terminal conditions nor to patients who have exhausted all other options.

7.It is likely to lead to increased litigation 

The bill will not reduce the number of patients harmed by doctors who act outwith the range of accepted treatments. Some argue it will risk increasing that number. It will not reduce the numbers of patients seeking redress for the harm they suffer. Those patients will seek to establish that the requirements under the bill have not been met. Thus the need for litigation will continue and, under the bill, new issues for litigation will arise. The lack of precise definition under the bill and the lack of any previous case law relevant to its interpretation means that it will be fertile ground for legal argument. I am not opposing this bill on the grounds that it will lead to less litigation. I am warning that it could well lead to more litigation.

8.It will increase the "red tape" for doctors 

Doctors who have to make treatment decisions will have to seek to comply with the decision making requirements under the bill in order to "cover their backs". At present all they are expected to do is to make a rational decision with which a responsible body of doctors would support. Under the bill there will be various requirements for consultation and notification.

9.It will put the most vulnerable patients at risk.

This bill will encourage maverick doctors by protecting them against negligence actions. This is not an exaggeration - after all  the bill's purpose is to give doctors freedom to try treatments which are not accepted by other doctors. For every one brilliant idea, there might be a hundred disastrous ones which do no good and cause harm. The patients most vulnerable to exploitation from mavericks are those who believe that mainstream medicine will not work or has failed to work. This bill will expose them to greater risk of harm.

10.It risks undermining the current regime for regulation for doctors. 

How can a doctor be found to be unfit for practice for giving harmful treatment if he/she has acted in accordance with the requirements of an Act of Parliament in relation to the treatment he/she has given? Why should a new medicine be prohibited if it would not be negligent to use it? How will the bill sit alongside statutory and professional regulations? I believe that this bill will have significant consequences for professional regulation and the regulation of new medicines and devices.

Tuesday, 3 June 2014

The Saatchi Bill - Silk Purse or Pig's Ear?

As I write Lord Saatchi is due to present a new draft of his Medical Innovation Bill to the House of Lords on 5 June. I believe this will be a second reading.

I am not a constitutional lawyer, but am mystified as to how a parliamentary process which sets up a public consultation on a particular draft (Draft X) can then proceed to debate and vote on a new draft (Draft Y) before the results of the consultation on Draft X are published and with no apparent intention to consult on Draft Y? Is this how a mature parliamentary democracy is meant to work? How can parliament vote without knowing what the responses were? I trust that at least one peer will ask Lord Saatchi what the responses were from the BMA, GMC, NHSLA, MPS, MDU, Royal Colleges etc.

We also now have a parliamentary process in which the government will allow a signature to a petition organised by an individual to be treated as a formal response to a formal governmental consultation. So Lord Saatchi claims 18,000 + positive responses and fewer than 100 against the Bill, yet we know some of those against, such as the BMA, represent thousands of doctors. The BMA's response counts as one response, but Lord Saatchi's team response counts as 18,000 responses. What an exciting precedent for future law-making!

To the new draft.

It is a slimmed down version of Draft X, and slightly fitter, but the essentials remain the same.

You can find it here if you scroll down the pages of briefing notes.

Clause 1(2) is almost as was - see previous posts. Clause 1(3) encapsulates the much more prolix provisions in the previous draft which were intended to ensure that any innovation was "responsible".
It should be noted that, aside from the requirement for the patient's consent, the other elements of 1(3) are still all subjective. A doctor must consult, but he can ignore the views of others. He or she must report the decision, but it does not have to be authorised. The doctor must give consideration to all the matters which the doctor considers to be relevant.

It cannot be over-emphasised that this bill would allow a doctor to decide to give treatment which no other doctor supports. Innovation is not defined and so the bill will sanction any decision to give treatment, whether innovative or not.

For example. Dr A firmly believes Vitamin Z capsules will cure a particular cancer. He consults with colleagues who warn him against it, but he believes it is the right course of action and he reports his decision to treat Patient Y in that way. Patient Y consents. Patient Y could have surgery and chemotherapy which would leave her with a 70% chance of surviving 5 years but she has faith in Dr A and wishes to undergo the vitamin treatment he will supply to her for a mere £5,000.

I believe Lord Saatchi's bill would support that doctor. Worse still, when Patient Y dies earlier than she needed to have died, her family would have have no redress - the bill is designed to stop them obtaining justice.

Please do not listen to the siren calls that this bill requires treatment to be agreed in advance by senior doctors. It does not require the agreement of any other doctor. Consultation is not the same as agreement. The whole purpose of the bill is to prevent a doctor being found negligent who acts without the support of other doctors.

As before this draft does contain a provision (now at 1(4)(a) that nothing in the section,

"permits a doctor to administer treatment for the purposes of research or for any purpose other than the best interests of the patient".

If this is an objective test - was the treatment actually in the best interests of the patient - then Dr A would be in trouble. If it is a subjective test - does Dr A believe the treatment is in the patient's best interests - then Patient Y is in trouble. However, if the former, then what is the point of having this bill? Treatment which is indeed in the best interests of the patient will not have caused additional harm to the patient and there will be no recourse to the common law of negligence. If it is in the patient's best interests then the decision to give the treatment cannot have been negligent. Also, this bill purports to "bring forward" the Bolam test to the point when treatment decisions are made, rather than when scrutinised in court years later. But, you cannot determine whether treatment was in fact in the best interests of the patient until the effects of that treatment have become clear. So, this must be intended to be a subjective test - what does the doctor believe is in the patient's best interests, in which case, it is the patient who is in trouble.

The new draft contains a new provision. Clause 1(4)(b) provides that nothing in it

"abolishes any rule of the common law in accordance with which a decision to innovate is not negligent if supported by a responsible body of medical opinion".

Thus if a doctor is not negligent at common law, this Bill will not render him/her liable in negligence. If the treatment would be or is supported by a responsible body of medical opinion, it will not be negligent just because the doctor has not consulted or reported the decision to treat. However, the bill certainly does not preserve the Bolam test. It does bypass the rule of common law that a decision to treat is negligent if not supported by a responsible body of medical opinion.

Doctors' representative bodies which have published their responses to the consultation agreed that the current common law of negligence is no barrier to responsible innovation. The premise of this bill is that it is a barrier. The premise is wrong. The bill is not needed. Legislation directed to the resourcing and regulation of new treatments and research would be much more effective. Worse still, this bill remains potentially dangerous. It will provide a defence to doctors who harm patients by providing treatment which no other doctor supports. It will remove a right of redress to those patients and their loved ones. And for whose benefit?

That is a poor way of paying tribute to those who have died of cancer and other terminal conditions.